"He who controls the narrative, controls the debate."
In this particular American political season, one would have to be close to stage four Coma to doubt the veracity of those words. But we have plenty of examples in American medicine that make the same statement. One version that still amazes me is the notion that the raw data from a clinical trial of medication is treated as proprietary, intellectual property. The rationale is that releasing it might breach patient confidentiality, or expose commercially confidential information. They’re not "patients," they are "subjects" who volunteered for one thing. And what’s commercially confidential about their response to an intervention? Yet, in spite of the uproar, industry has held onto that right, making access to data still a rare exception, and very difficult at that. Our re-write of Study 329 was an enormous undertaking, primarily because of the restrictive window we were given to access the data. The sensible program adopted by the European Medicines Agency to release data has likewise been essentially undermined. Data Transparency is on the lips of everyone, including industry – only it just hasn’t happened in real life. The intellectual property meme continues to control the narrative.
Alastair Matheson has recently clarified another example – ghost writing. Most industry-funded clinical trials are conducted by commercial Contract Research Organizations [Clinical Research Organizations][CROs]. The resultant data is analyzed by company statisticians working with the companies; marketing departments, and a summary of the results are forwarded to a professional medical writers who create a first draft. At that point, the recruited COI-ladened KOL authors enter the review process along with the industry-doctors also on the author by-line. In the past, the medical writers were either unmentioned or mentioned as editorial support. When challenged as ghost-writers – the medical writers/pharma denied it. But then came the new narrative pointed out by Matheson. They claimed that if they’re mentioned in the Acknowledgements by name, they’re no longer ghosts. As absurd as that is, they’ve stuck to the explanation like super-glue.
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By ignoring the requirement to declare outcomes a priori in the ClinicalTrials.gov database, they’ve undermined having a certified statement as an anchor that couldn’t be changed.
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Even more damning, they’ve ignored even posting the RESULTS until relatively recently.
Between October 2015 and January 2016, the COMPare team systematically checked every trial published in the top five medical journals, to see if they misreported their findings.
And what they found:
| TRIALS CHECKED |
TRIALS WERE PERFECT |
OUTCOMES NOT REPORTED |
NEW OUTCOMES SILENTLY ADDED |
| 67 | 9 | 354 | 357 |
And when they wrote the Journals:
| LETTERS SENT |
LETTERS PUBLISHED |
LETTERS UNPUBLISHED [1 mo] |
LETTERS REJECTED |
| 58 | 18 | 8 | 32 |
I encourage you to look at their website, particularly the Blog and the different reactions among the journals. It’s straightforward. Each study looked at is well documented. See also Goldacre’s academic colleague, , and his review of the FDA Requirements. These results couldn’t be clearer.
But you probably didn’t know that changing outcomes was still that common, well in the majority. You and I have been reading the narrative being handed to us with industry falling all over itself to aver their commitment to the cause of Data Transparency and ClincalTrials.gov compliance, stroking the largely fictitious narrative. And if you’re a denizen of that web-site like some of us, you’ve noticed how recently the RESULTS database has been filled out on-time [for a change]. Maybe not on point, but at least on-time.
I frankly doubt that even the people at the FDA, the NIH, or ClinicalTrials.gov actually realize how common this practice of changing outcomes really is or why it’s such a game changer. And it’s likewise probable that few know why prompt a priori Registration and RESULTS posting on that site matters so much. The recent reforms by the NIH and ClinicalTrials.gov focus on the importance of using that web site, filling it out, but don’t provide for checks on its content [see what to do? the final rule?…] and allow for unnecessary delays in populating both the outcome parameters at registration and the RESULTS. Both of those things are mission critical…
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